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OpenTrials
Completed

NCT Number: NCT02066740

EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.

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Key information

Conditions

Peripheral Arterial Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Weiden

Weiden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
  • or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.

Exclusion criteria

  • Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.

Treatment and study plan

EverFlex™ stent with Entrust™ delivery system

Device

Primary outcomes

  1. Absence of Stent Elongation

    Time frame: Intra operative

    Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length

  2. Successful Stent Deployment

    Time frame: Procedure

    Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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